Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH

NCT ID: NCT05421949

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2022-08-30

Brief Summary

The purpose of this study is to examine N-terminal pro brain natriuretic peptide (NT-proBNP) and brain natriuretic peptide (BNP) biomarkers in a number of different settings including assessing the repeatability of laboratory and point of care testing (POCT), the effect of a time delay and exercise have on laboratory measurements. Also to compare the clinical and analytical performances of NT-proBNP and BNP POCT samples across the spectrum of disease severity and finally assess whether POCT in PAH can detect change in patients commencing or escalating PAH treatment.

Detailed Description

• Patients that are attending clinical appointments will be approached to ask if they will take part in the study.
• Patients will be assessed at two separate visits.
• Patients will be randomised to either exercise or rest group on their 1st visit. On the 2nd visit patients will be asked to participate in the alternate group to what they completed on their previous visit.
• At each visit they will have 2 blood samples taken, at time point 1 and at time point 2 (T1 and T2). These will be taken at least one hour apart, each with a period of at least 15 mins rest in the sitting position prior to sampling.
• On one of these two visits the patient will undergo exercise testing between T1 and T2.
• In addition, a further laboratory testing tube will be taken for a delayed NT-proBNP. This will be subjected to gentle agitation (laboratory rotator) for 48 hours prior to processing to simulate, in a controlled environment, the effect of transport and delay on sample measurement.
• Retrospectively information will be collected regarding the patient's disease severity and any change to treatment that occurred between the two visits.
• A total of 40 patients with be sampled with an interim analysis after 20 patients.

Conditions

Pulmonary Artery Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exercise

Patients who have been randomised to the exercise group will be asked to undertake a incremental shuttle walking test following their initial blood tests.

Exercise group

Intervention Type: OTHER

Incremental Shuttle Walking Test

No Exercise

Patients who have been randomised to the exercise group will be asked to rest for 60 minutes following their initial blood tests.

No interventions assigned to this group

Interventions

Exercise group

Incremental Shuttle Walking Test

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who have met the criteria for The Sheffield Teaching Hospitals Observational Study of Patients with Pulmonary Hypertension, Cardiovascular and other Respiratory Diseases (STH-ObS)
• Patient diagnosed with Group 1 PAH, including IPAH, HPAH, PAH-CTD but excluding PAH-CHD. Mean pulmonary artery pressure >20mmHg, PAWP ≤15mmHg and PVR >240 dynes.
• Willing to participate in the study and able to provide informed consent

Exclusion Criteria

• Diagnosed with PAH-CHD or any non-group 1 PH
• Creatinine clearance < 15 ml/min/m2

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

Durrington C, Battersby C, Holt L, Fairman A, Strickland S, Salisbury T, Turton HA, Watson L, Smith I, Roman S, Ablott J, Hitchcock F, Roddis C, Oakes E, Wilshaw H, Woodrow I, Armstrong I, Charalampopoulos A, Elliot CA, Hameed A, Hamilton N, Hurdman JA, Lawrie A, Middleton JT, Zafar H, Rothman AMK, Condliffe R, Lewis RA, Kiely DG, Thompson AAR. NT-proBNP and BNP Testing in Pulmonary Arterial Hypertension: Point-of-Care and Remote Monitoring. Respirology. 2025 Jul 3. doi: 10.1111/resp.70087. Online ahead of print.

Reference Type: DERIVED

PMID: 40611611 (View on PubMed)

Other Identifiers

STH20981

Identifier Type: -

Identifier Source: org_study_id